Stress Urinary Incontinence
Conditions
Keywords
Urinary Incontinence, Urinary Incontinence, Stress, Urination Disorders, Urologic Diseases, Urological Manifestations, Signs and Symptoms
Brief summary
The Solace European Confirmatory (SOLECT) Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.
Detailed description
Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months. All patients undergoing sham treatment are treated at 3 months.
Interventions
DEVICESolace Bladder Control System
Subjects may undergo treatment every 12 months until study completion.
DEVICESolace Sham Treatment
Sham procedure that resembles treatment with the Solace Bladder Control System
Sponsors
Solace Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female 18 years of age or older with stress urinary incontinence (SUI) * Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment * Willing to undergo cystoscopic procedures required and 36 month follow-up * On stable medication for a minimum of 3 months * Free of local genital skin infection * Positive Pad Weight Test * Free of impassable urethral strictures, trauma or necrosis
Exclusion criteria
(must answer NO): * Pregnant or planning to become pregnant during the study period * Non-ambulatory or bedridden or physically unable to complete test exercises * Morbidly obese (defined as BMI ≥ 40 kg/m2) * Bladder infection (including bladder inflammation or edema) or UTI within 3 months * History of recurrent urinary tract infections * Prior surgical procedure for incontinence within the past 6 months * Is taking medications for urinary incontinence other than anticholinergics * History of kidney stones * Has a prosthetic heart valve * Unable to tolerate any form of antibiotic * Taking anticoagulation therapy, other than aspirin * Has urinary incontinence due to Intrinsic Sphincter Deficiency (ISD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in quality of life as assessed by pad weight tests assessments and questionnaires | 3 Months | Comparison of increases in pad weight test and patient reported outcomes on questionnaires. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-related adverse events | 3 Months | Site-reported adverse events designated as related to the treatment. |
| Severity of treatment-related adverse events | 3 Months | Site-reported adverse events designated as related to the treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all adverse events | 36 Months | Rate of incidence of all adverse events for all patients |
| Improvement in quality of life in all patients assessed with pad weight tests and questionnaires | 36 Months | — |
| Severity of all adverse events | 36 Months | Severity of all adverse events for all patients |
Countries
Belgium, Italy, Netherlands
Outcome results
None listed